Post-stroke Gait Rehabilitation Using the SHAJA-R Exoskeleton

NCT ID: NCT07035730

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-07
• Study Completion Date: 2026-12-31

Brief Summary

The goal of this clinical trial is to evaluate the safety, reliability, and short-term effectiveness of SHAJA-based training in improving walking velocity and endurance in post-stroke patients.

The main questions it aims to answer are:

• Does the SHAJA-based training improve walking velocity and endurance in post-stroke patients compared to conventional gait training?
• Is the SHAJA exoskeleton safe and reliable?

Researchers will compare the SHAJA-based training to a conventional gait training to see if the former works to improve walking ability.

Participants will:

• Perform six SHAJA-assisted gait training sessions or six conventional gait training sessions
• Perform five assessment sessions

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHAJA first, then conventional

Patients will perform the SHAJA-assisted gait training during the first period of the trial followed by a conventional gait training during the second period of the trial

Group Type: EXPERIMENTAL

Unilateral hip exoskeleton

Intervention Type: DEVICE

Unilateral hip exoskeleton assisted gait training. Gait training will consist of overground walking with the exoskeleton SHAJA for 30-40 minutes.

Conventional gait training

Intervention Type: BEHAVIORAL

Conventional gait training will consist of overground walking without the exoskeleton SHAJA for 30-40 minutes.

Conventional first, then SHAJA

Patients will perform the conventional gait training during the first period of the trial followed by a SHAJA-assisted gait training during the second period of the trial

Group Type: EXPERIMENTAL

Unilateral hip exoskeleton

Intervention Type: DEVICE

Unilateral hip exoskeleton assisted gait training. Gait training will consist of overground walking with the exoskeleton SHAJA for 30-40 minutes.

Conventional gait training

Intervention Type: BEHAVIORAL

Conventional gait training will consist of overground walking without the exoskeleton SHAJA for 30-40 minutes.

Interventions

Unilateral hip exoskeleton

Unilateral hip exoskeleton assisted gait training. Gait training will consist of overground walking with the exoskeleton SHAJA for 30-40 minutes.

Intervention Type: DEVICE

Conventional gait training

Conventional gait training will consist of overground walking without the exoskeleton SHAJA for 30-40 minutes.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• cerebral stroke, at least 3 months from cerebral event
• ability to ambulate with no more than minimal contact assistance, even with aids (Functional Ambulation Classification, FAC >= 43)
• self-selected walking velocity in the range [0.3-0.85] m/s
• anthropometry consistent with the specifications of the tested devices
• gait impairments that may benefit from hip assistance, e.g. hip weakness in flexion and/or extension (Medical Research Council, MRC, Scale for Muscle Strength >2 and <5 for flexion and extension)

Exclusion Criteria

• Modified Ashworth Scale >3 at the hip and/or ankle joints
• Poor cognitive skills (corrected Mini-Mental State Examination, MMSE < 21)
• inability to follow verbal 3 step commands
• severe aphasia causing inability to communicate with the investigators
• serious medical conditions (recent myocardial infarction in less than 3 months, uncontrolled congestive heart failure (CHF), uncontrolled hypertension, uncontrolled seizures)
• leg deep vein thrombosis less than 6 weeks ago
• other pre-existing neurological disorders (Parkinson's disease, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Dementia)
• severe anxiety or depression (State-Trait Anxiety Inventory-Y, STAI-Y > 44, and the Beck Depression Inventory-II, BDI-II > 19)
• severe osteoporosis
• severe hip / knee osteoarthritis with limitation of movement or significant pain
• use of a colostomy bag
• skin wounds, infection, or problems at device contact locations
• major orthopaedic surgery or fractures within the last 90 days (hip, knee, ankle, foot, spine)
• cardiac surgery within the last 3 months
• patient has recently or is currently participating in research that may influence, in PI's opinion, responses to study intervention
• pregnancy
• implanted cardiac devices, such as pacemakers or automatic defibrillators (AICD)
• use of assistive device that, in the PI's opinion, could interfere with SHAJA

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scuola Superiore Sant'Anna di Pisa

OTHER

Sponsor Role: collaborator

Centro Riabilitativo Villa Beretta

UNKNOWN

Sponsor Role: collaborator

Azienda Ospedaliero, Universitaria Pisana

OTHER

Sponsor Role: collaborator

Carmelo Chisari

OTHER

Sponsor Role: lead

Responsible Party

Carmelo Chisari

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Centro Riabilitativo Villa Beretta

Costa Masnaga, Italy, Italy

Site Status: NOT_YET_RECRUITING

SD Neuroriabilitazione - Azienda Ospedaliero Universitaria Pisana

Pisa, Italy, Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Giovanna Palumbo

Role: primary

gpalumbo2001it@yahoo.it

+390318544215

Stefania Dalise

Role: primary

stefania.dalise@ao-pisa.toscana.it

+39050994282

Other Identifiers

0003812/2025

Identifier Type: -

Identifier Source: org_study_id